Look be­yond the slo­gan

Modern Healthcare - - OPINIONS | LETTERS -

Joe Carl­son’s in­ter­view with out­go­ing Fed­eral Trade Com­mis­sion Chair­man Jon Lei­bowitz (“Cham­pi­oning con­sumers,” Feb. 9, p. 18) re­peated one of the chair­man’s fa­vorite catch­phrases, “pay- for-de­lay,” in the mat­ter of patent set­tle­ments, but missed the point. As you might ex­pect, there is more to the com­plex mat­ter than a slo­gan, and that is why, over the past eight years, the courts re­peat­edly have said that it is the patent, not the set­tle­ment that keeps the generic off the mar­ket.

Some facts should not be over­looked:

The set­tle­ments are pro-com­pet­i­tive be­cause they al­low the gener­ics to en­ter the mar­ket months and even years ahead of brand patent ex­pi­ra­tions. Not one patent set­tle­ment agree­ment has ever de­layed the mar­ket en­try of the generic drug past the ex­pi­ra­tion of the ac­tual brand patent.

Patent set­tle­ments are trans­par­ent. Un­der fed­eral law en­acted in 2003, ev­ery patent set­tle­ment agree­ment is re­quired to be submitted to the FTC and the Jus­tice De­part­ment within 10 days of be­ing reached. Th­ese two fed­eral agen­cies have author­ity un­der that law to chal­lenge those agree­ments they con­sid­ered anti-com­pet­i­tive or anti-con­sumer.

Over the past decade, generic drug man­u­fac­tur­ers have pre­vailed in only 48% of the nearly 400 drug patent lit­i­ga­tion cases. This means that with­out set­tle­ments, con­sumers have less than a 50-50 chance of gain­ing ac­cess to the lower-cost generic medicines prior to brand patent ex­pi­ra­tion. But when a patent set­tle­ment is reached, con­sumers gain ac­cess to the lower-cost generic medicines prior to patent ex­pi­ra­tion 100% of the time.

And be­cause of im­proved ac­cess, patent set­tle­ments save con­sumers bil­lions of dol­lars ev­ery year. In 2011, ac­cord­ing to IMS Health, 17 of the 22 gener­ics that went on the mar­ket were the re­sult of patent set­tle­ments.

When the whole story is told, read­ers will agree that patent set­tle­ments are pro-com­pet­i­tive and pro-con­sumer.

Ralph G. Neas Pres­i­dent and CEO Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion



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